UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062759 |
|---|---|
| Receipt number | R000071853 |
| Scientific Title | Identification of factors determining gait in patients with joint, spinal, and neurological disorders using biomechanical analysis |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/09/01 08:34:59 |
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Basic information
Public title
A study of changes in gait before and after treatment and factors associated with gait in patients with joint, spinal, and neurological disorders
Acronym
JSN-Gait Study
Scientific Title
Identification of factors determining gait in patients with joint, spinal, and neurological disorders using biomechanical analysis
Scientific Title:Acronym
JSN-Gait Biomechanics Study
Region
| Japan |
Condition
Condition
Osteoarthritis, osteonecrosis of the femoral head, chronic spinal disorders, Parkinson's disease, and parkinsonian syndromes
Classification by specialty
| Neurology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to quantitatively evaluate gait before and after treatment in patients with joint, spinal, and neurological disorders using biomechanical analysis and to identify factors associated with gait and changes in gait after treatment by examining their relationships with patient characteristics, physical findings, imaging findings, and patient-reported outcomes.
Basic objectives2
Others
Basic objectives -Others
Exploration and identification of factors associated with gait and changes in gait before and after treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait parameters assessed before treatment and within one year after treatment, including gait speed, step length, stride length, cadence, step width, gait cycle time, stance time, swing time, single-support time, double-support time, step-time variability, stride variability, gait asymmetry, toe clearance, turn duration, turn velocity, and number of steps during turning. Associations of these gait parameters with patient characteristics, physical findings, imaging findings, and patient-reported outcomes, as well as factors associated with changes in gait parameters after treatment, will be evaluated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Surgical treatment for joint and spinal disorders and pharmacological treatment for Parkinson's disease and parkinsonian syndromes are provided as part of routine clinical care. Treatment is determined by the attending physician according to each patient's clinical condition, and no treatment is assigned by the study protocol. Gait, physical findings, imaging findings, and patient-reported outcomes are assessed before treatment and within one year after treatment.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing surgical treatment for osteoarthritis, osteonecrosis of the femur, or chronic spinal disorders at our institution, or patients receiving treatment for Parkinson's disease or parkinsonian syndromes at our institution
2. Patients who can walk on level ground without assistance at the time of study enrollment
3. Patients who are able to answer questions regarding their subjective symptoms
4. Patients who are able to understand and respond to instructions and questions related to the study procedures
Key exclusion criteria
1. Patients who are unable to complete patient-reported outcome assessments because of dementia or other conditions
2. Patients considered by the investigators to be unable to participate in or complete follow-up because of their health status
3. Patients considered by the investigators to have severe psychosocial disorders that could substantially affect study participation or study outcomes
4. Patients scheduled to participate in another clinical trial or clinical study within 30 days
5. Patients in a protected status, including those who are unable to provide valid consent because of impaired decision-making capacity
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Tsuda |
Organization
Ehime University Hospital
Division name
Orthopaedic Surgery
Zip code
791-0216
Address
Shitsukawa, Toon City, Ehime, Japan
TEL
0899605343
tsuda.takashi.hz@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Tsuda |
Organization
Ehime University Hospital
Division name
Orthopaedic Surgery
Zip code
791-0295
Address
Shitsukawa, Toon City, Ehime, Japan
TEL
0899605343
Homepage URL
tsuda.takashi.hz@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071853
